cin series on opioid overuse, webinar 9 — complex chronic ... · –sedentary but intermittent...

Complex Chronic Pain, Opioid Prescribing and Opioid Use Disorder: Pitfalls, Pearls, and New Directions / William Becker, MD

June 23, 2017 / CSAM – Treating Addiction in the Primary Care Safety Net (TAPC) Webinar Series

William C. Becker, MD Assistant Professor, General Internal Medicine

VA Connecticut Healthcare System Yale University School of Medicine

June 23, 2017

Complex chronic pain, opioid prescribing and opioid use disorder:

Pitfalls, pearls and new directions

I have no conflicts of interest related to the content of this presentation.



Learning objectives

•  Appreciate chronic pain and opioid use disorder as distinct entities that commonly co-occur

•  Understand complexities of and tips for making an opioid use disorder diagnosis in patients on long-term opioid therapy for chronic pain

•  Learn about potential roles for buprenorphine in managing complex chronic pain

Poll Question In a given month, I write approximately this number of prescriptions for long-term opioid therapy: A) 0, I’m not a prescriber B) 0, I’m a prescriber but I don’t prescribe C) a handful (1-5) D) 6-20 E) > 20



Poll Question Complex chronic pain and related opioid issues are: A) The most challenging thing I treat clinically B) Among the most challenging things I treat C) Sometimes challenging, sometimes not D) Not particularly challenging E) Downright easy F) N/A; I’m not a clinician

Chronic pain: ubiquitous and costly •  Point prevalence: 25% in U.S. adults; 10% with disabling

chronic pain that limits work and family activity

•  Second most common reason for outpatient visits

•  Annual national economic cost estimated up to $635 billion



Woolf CJ. Pain 2011

Chronic pain: neuronal plasticity and central sensitization

Neuronal plasticity Peripheral nerve injury à recruitment of macrophages and glial cells à dysregulated nerve regeneration of c-fibers Central sensitization Excess of c-fibers in dorsal horn à lowered pain thresholds

Complexity of chronic pain

Deardorff, WW. APA 2008.



Opioid analgesics

Morphine equivalent dose •  Method of standardizing potency across various opioid

compounds

•  Based on equianalgesic tables from dose ranging studies

•  Example: 20 mg oxycodone TID

= 90 mg morphine equivalent daily dose

Equianalgesic dose (MG)

Opioid (oral)

30 Morphine

7.5 Hydromorphone

20 Oxycodone

30 Hydrocodone

http://www.agencymeddirectors.wa.gov/Calculator/DoseCalculator.htm



Activation of mu receptors

Sequelae of long-term opioids Tolerance à higher doses required to achieve same analgesic effect over time

+ Withdrawal à characteristic symptoms upon abrupt cessation or lowering of opioid dose ______________________________________

“PHYSIOLOGIC DEPENDENCE”

Opioid-induced hyperalgesia à paradoxical worsening of pain with higher doses



Opioid use disorder (DSM-5) Physiologic sequelae •  Tolerance •  Withdrawal •  Opioid craving

Loss of control •  Greater amounts of use or

longer period of use than intended

•  Persistent desire but unsuccessful efforts to cut down

•  Inordinate amount of time obtaining, using, or recovering

Adverse consequences Summary of 5 criteria: •  Important social,

occupational or recreational activities given up or reduced due to opioid use or recurrent opioid use despite physical or psychological problems caused or worsened by use

DSM-5 criteria vs. pain literature guided criteria

Adapted from Ballantyne & Stannard PAIN: CLINICAL UPDATES • DECEMBER 2013

DSM-5 Pain literature

•  Failure to fulfill major roles •  Multiple prescribers

•  Use in physically hazardous situations

•  Frequent ED visits

•  Persistent interpersonal problems

•  Multiple drug “allergies

•  Unsuccessful efforts to cut down •  Running out of meds early

•  Great deal of time obtaining •  Frequent phone calls to clinic

•  Giving up activities •  Prescription losses

•  Craving •  Anger/temper with clinicians/staff

•  Continued use despite knowledge of harm



False dichotomy Is this pain or is this opioid use disorder? (..if it’s “real pain”

and not addiction, opioids are probably indicated)

Ø  The patient *HAS* pain. Ø  The patient may also have opioid use disorder.

Ø What is the optimal treatment plan for the pain? Ø What is the optimal treatment plan for pain if opioid use disorder

is co-occurring?

Other important toxicities •  Constipation •  Itching •  Nausea/vomiting •  Hypogonadism •  Opioid-induced hyperalgesia •  Sedation •  Impaired cognition •  Falls/motor vehicle accidents •  Blunted respiratory drive •  Non-fatal and fatal overdose



Odds of overdose by increasing dose

Dunn Gomes Bohnert

Dose* (mg/day) HR (95% CI) OR (95% CI) HR (95% CI)

1-<20 1.00 (REF) 1.00 (REF) 1.00 (REF)

20-<50 1.2 (0.4-3.6) 1.3 (0.9-1.8) 1.9 (1.3-2.7)

50-<100 3.1 (1.0-9.5) 1.9 (1.3-2.9) 4.6 (3.2-6.7)

≥100 or 100-199 11.2 (4.8-26.0) 2.0 (1.3-3.2) 7.2 (4.9-10.7)

≥200 2.9 (1.8-4.6)

*morphine equivalent

Dunn et al. Annals IM 2010; Gomes et al. Archives IM 2011; Bohnert et al. JAMA 2011

Evidence for long-term use •  “Despite the identification of 26 treatment groups with

4768 participants, the evidence regarding the effectiveness of long-term opioid therapy in chronic non-cancer pain is too sparse to draw firm conclusions...”

•  Medium effect size in study completers, but they were small proportion of sample

•  No long-term studies included functional outcomes

Noble, M. The Cochrane Collaboration. 2010



What are we treating? •  The people who “respond” to opioid treatment/stay on

opioids long term may be actually medicating emotional distress: “Chemical coping”

•  Mental health diagnoses increase risk of overdose and other harms.

•  Some experts believe opioid treatment interferes with effectiveness of actual evidence-based MH treatment.

Sullivan and Ballantyne. Arch IM, 2012.

Opioids for chronic pain: important limitations

•  Central sensitization—driver of much of chronic pain--may not be responsive to long-term opioids.

•  Opioids may initially “work” but the body adapts to them, necessitating higher doses.

•  Higher doses long-term à increased risk of toxicity/adverse effects, both acute and chronic.

•  Are “responders” mostly benefitting from treatment of emotional distress, for which better/safer treatments exist?



Lockstep trends in prescribing and harm

http://www.nsc.org/RxDrugOverdoseDocuments/evidence-summary-opioid-sales-use-and-increase-in-opioid-overdose.pdf

CDC Guideline for Prescribing Opioids for Chronic Pain

Ø Non-pharmacologic therapy and non-opioid pharmacologic therapy are preferred for chronic pain.



Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation

Ø If benefits do not outweigh harms of continued

opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.

Assessing Risk and Addressing Harms of Opioid Use

Ø Clinicians should offer or arrange evidence-based treatment for patients with opioid use disorder when that diagnosis is evident.



Mr. M is 58-year-old man with chronic low back pain who presents to transfer care; pain specialist will no longer see him because he lost private insurance. CC: “I’m in a rut.”

PMHx: lumbar spondylosis, PTSD

Pertinent data: – Morphine SA 60 mg TID, oxycodone IR 10 mg q6 hours; – Opioid therapy started 2004 at 30 mg MEDDà240 mg MEDD – Lorazepam 0.5 mg TID – Sedentary but intermittent high intensity activity

ROS: Daily moderate-severe pain interfering with ADLs, nightmares, snoring, erectile dysfunction, feels blah most days

Case

Opioid use disorder (DSM-5) Physiologic sequelae •  Tolerance •  Withdrawal •  Opioid craving Loss of control •  Greater amounts of use or


•  Repeated unsuccessful efforts to cut down


Adverse consequences Summary of 5 criteria: •  Important social, occupational

or recreational activities given up or reduced due to opioid use or recurrent opioid use despite physical or psychological problems caused or worsened by use

Physiologic dependence



Poorly controlled chronic pain with pervasive pain-related functional interference à BENEFIT is absent

Poorly controlled PTSD

Sleep-disordered breathing

Erectile dysfunction

Elevated risk of overdose death (240 mg MEDD) and physiologic dependence

à HARM/RISK are prohibitive

Problem list

Options A)  Opioids don’t work for chronic pain and I am not comfortable

writing those doses; you’ll need to ask someone else B)  There is no imminent safety issue; continue at current dose for

now but will start taper with 2nd prescription C)  It’s clear that harm is already outweighing benefit. I can work

with you to get you to a safer dose (or off altogether), but that will need to start with the first prescription I write.

D)  Arrange inpatient detoxification



Framing the low benefit conversation

•  Empathy •  Concern •  Shared responsibility •  Optimism

Tapering/discontinuing in low benefit

•  Very little evidence to guide •  Patients report increased willingness when offered

empathy, support, reassurance

•  Anecdotal evidence:

–  Start with long-acting: decrease in 5-10% of overall dose *rarely* noticeable

–  Success in each step down breeds success

–  Offer pt option to “pause” PRN

•  See Dr. Joseph Frank’s CSAM webinar https://player.vimeo.com/video/215259225



Plan for this patient…

•  Optimize pain care – Behavioral therapies – Physical activation – Rational non-opioid pharmacotherapy

•  Optimize opioid management – Decrease dose – Therapeutic monitoring: Treatment

agreement, UDTs, PDMP checks

Evidence-based high value chronic pain care

Behavioral therapies

Physical activation

Rational pharmaco therapy

SELF MGMT SELF EFFICACY

Promotion of Healthy Behaviors Addressing Co-Morbidities

Integrated Health System



Evidence-based non-pharmacologic treatments for chronic pain

Physical activation •  Structured exercise •  Physical therapy •  Yoga •  Tai Chi •  Aqua-therapy

Behavioral treatments •  Cognitive behavioral therapy •  Mindfulness based stress

reduction

Other techniques •  Chiropractic •  Acupuncture •  Trigger point injections •  Intra-articular injection •  TENS •  Nerve blocks

Non-opioid pharmacologic options

•  NSAIDs •  Acetaminophen •  Gabapentanoids (gabapentin, pregabalin)

•  SNRIs (duloxetine, venlafaxine) •  Topicals (capsaicin, NSAIDs, lidocaine)



Optimizing treatment of co-occurring conditions

•  Major depression, anxiety, other MH conditions

•  Diabetes, OSA and other chronic conditions

•  Substance use disorders

Therapeutic monitoring



Assess and re-assess the 5 As

1.  Analgesia: 11- pt Numeric Rating Scale 2.  Activities of daily living (function): “Your goal was to

get back in your walking routine. How is it going?” 3.  Adverse effects: detailed questions 4.  Addiction/overuse: Is the patient oversedated? Is the

patient running out early? Does the urine drug test unprescribed drugs/meds?

5.  Adherence to the treatment agreement: Is the patient no-showing appointments? Does the patient have multiple prescribers?

Urine drug testing

•  Performs better than physician impression

•  Learn how to order and interpret first; *then*, incorporate into clinical practice

Katz, Fanciullo. Clin J Pain, 2002



Goals of urine drug testing •  Improve Patient Care and Safety:

–  Facilitates doctor-patient communication –  Provides objective information –  Confirms use of prescribed medication: Adherence

testing –  Confirms lack of use of non-prescribed medications

and illicit drugs

Heit,H.A. and Gourlay, D.L. J Pain Sympt Mgt. 2004.

How to discuss UDT •  New patient initiating on opioids: (as part of treatment

agreement discussion) –  “This is our routine practice as a patient safety issue.”

•  Patient says: “But I’m not a drug addict”:

–  “Routine testing…not singling anyone out.”

•  Patient says: “I refuse”: –  “We can’t prescribe if we’re unable to do the routine safety

monitoring discussed in the treatment agreement.”

Heit, H.A.; Gourlay, D.L. J Pain Sympt Mgt. 2004.



Laboratory testing procedures

First: Screening:

– Enzyme-Mediated Immunoassay (EIA) If any unexpected findings, then: Confirmatory:

– Gas Chromatography/ Mass Spectrometry

Katz, N. and Fanciullo, G.J. Clin J Pain. 2002.

Sample two-stage EMIT then GC/MS (rx is oxycodone CR 20 mg TID) •  EMIT:

–  Amph (-) –  BZD (-) –  Barb (-) –  Cannab (-) –  Cocaine (-) –  Methadone (-) –  Opiate (+)

–  Oxycodone (+) –  PCP (-)

•  Opiate GC/MS: –  Codeine (-) –  Morphine (-) –  Hydrocodone (-) –  Hydromorphone (-) –  Oxycodone 1000 ng/

ml –  Oxymorphone 730

ng/ml –  6-acetylmorphine (-) –  Meperidine (-)



Metabolism of Opioids

Gourlay,D.L.andHeit,H.A.PainMed.2009;10:(S2):S115-S123.

Identifying opioid use disorder •  Your role:

–  Partner with the patient –  Be transparent/forthright/non-judgmental

•  In the treatment agreement: –  I want to ensure your safety –  I will be monitoring [in these ways] –  Specifically, I’m looking for [safe use behavior] –  If you demonstrate lack of safety, it is my duty to stop the

therapy and transition you to safer therapy

•  If patient evidences recurrent problematic behavior, that suggests loss of control, requiring close evaluation for opioid use disorder



Patient started the taper…

•  Felt that he was totally pre-occupied with pill count

•  Was craving next dose despite absence of withdrawal symptoms

•  Frustrated that he wanted to cut back but couldn’t

OUD pattern has emerged Physiologic sequelae •  Tolerance •  Withdrawal •  Opioid craving Loss of control •  Greater amounts of use or


•  Repeated unsuccessful efforts to cut down


Adverse consequences Summary of 5 criteria: •  Important social, occupational

or recreational activities given up or reduced due to opioid use or recurrent opioid use despite physical or psychological problems caused or worsened by use

Physiologic dependence



Buprenorphine: a partial µ agonist 100

90

80

70

60

50

40

30

20

10

0

%

Opioid dose

Full Agonist

Partial Agonist (Buprenorphine)

Full Antagonist

Opioid effect:

sedation, respiratory depression

Increasingly, we are offering bup/nx before OUD develops

•  “We now know more about safety problems related to opioids and we are concerned about your health and safety. We recognize that we/(“the system”) prescribed you these medications so now we want to help you be safer while still managing your pain.”

•  Constrained choice: slow taper (e.g. 10% every 2-4 weeks) vs. quick taper off and rotation to buprenorphine.

•  Possible outcomes if choosing bup/nx: –  Bup/nx works better for pain/overall well-being à WIN

–  Bup/nx works about the same à WIN

–  Bup/nx nowhere near as effective à try to stay on 2-3 weeks, potentially restart full agonists at <50% prior dose



A word about dose, etc •  Difficult to make conclusive statements…Rough

guidelines: –  Pre rotation dose > 120 mg MEDD à 4 mg TID –  Pre rotation dose 60-120 mg MEDD à 2 mg TID –  Pre rotation dose <60 mg MEDD à 2 mg BID

•  For induction of patient on > 120 mg MEDD: –  Halve their dose every day until ~100-120 mg MEDD à –  Stop; Await withdrawal –  Start bup/nx –  We do ~90% “home inductions”

•  If prescribing for pain only, X-license not needed *OR* if you have X-license, for pain does not count towards cap

Document

•  Indication for treatment •  Discussion of potential harm and benefit •  Treatment plan •  Results of assessment and reassessment with

each visit •  Response to problems



We are at a crossroads… •  There are many patients already on long-term opioid

therapy that would likely not have been started in the first place if we knew then what we know now.

•  For patients already on long-term therapy consider this stance: –  Continue if favorable benefit to harm/ratio –  Avoid dose escalation –  Be vigilant for indications to lower the dose/

discontinue, potentially rx bup/nx –  Avoid stigmatizing – patients are not “at fault” for

where things stand today.

Summary •  Chronic pain is common, marked by functional

disability and affective distress.

•  Evidence supports multi-modal treatment that promotes patient self management as the most effective management strategy.

•  Opioids have a limited role in chronic pain.

•  When used, opioids should be monitored carefully and discontinued when harm outweighs benefit. Buprenorphine can play a helpful role.



Friday,08/18/2017*Friday,09/22/2017

NEXTWEBINAR:Friday,07/28/2017HowtoBuildaControlledSubstanceReviewCommiHeeinYour

PrimaryCareClinic:Why?Who?How?

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